Regulatory Affairs

Development of regulatory strategies for medicinal products (incl. biotech products), review of documents and advice concerning meetings with authorities in Europe and United States.

Target clients: pharmaceutical companies, especially small and medium sized ones developing e.g. generic drugs which need support during the overall process of getting a medicinal products approved in various regions or on local level.

My regulatory service, including but are not limited to the following activities:

  • Support and review of IMPDs & INDs and other regulatory filings

  • Support for scientific meetings with authorities

  • Review of medical and technical summaries, expert reports and quality related documents

  • Assist regulatory procedures (Centralized, Decentralized, Mutual Recognition & NDA)

Back to previous page

Comments are closed.